Efficacy of a family-based cardiovascular risk reduction intervention in individuals with a family history of premature coronary heart disease in India (PROLIFIC): an open-label, single-centre, cluster randomised controlled trial.

BACKGROUND: Coronary heart disease, a leading cause of death globally, is amenable to lifestyle interventions. The family environment can affect the ability or willingness of individuals to make lifestyle changes. We aimed to investigate the efficacy of a targeted family-based intervention for reduction of total cardiovascular risk in individuals with a family history of premature coronary heart disease. METHODS: We did an open-label, cluster randomised controlled trial (PROLIFIC) in the families (first-degree relatives and spouses, older than age 18 years) of individuals with coronary heart disease who had been diagnosed before age 55 years. Patients with coronary heart disease diagnosed within the past year were selected from a tertiary care speciality hospital that provides care for patients from Kerala, India. Family members of selected patients who were bedridden or terminally ill, and individuals with a history of established cardiovascular heart disease and stroke were excluded, as were families with fewer than two eligible family members. Simple randomisation with computer-generated random numbers was used to randomly assign families to intervention and usual care groups (1:1). Participants in the intervention group received a comprehensive package of interventions facilitated by non-physician health workers, consisting of: screening for cardiovascular risk factors; structured lifestyle interventions; linkage to a primary health-care facility for individuals with established chronic disease risk factors or conditions; and active follow-up for adherence. The usual care group received one-time counselling and annual screening for risk factors. We obtained data on lifestyle, clinical, and biochemical characteristics at baseline and annually during the 2-year follow-up. The primary outcome was achievement or maintenance of any three of the following: blood pressure lower than 140/90 mm Hg, fasting plasma glucose lower than 110 mg/dL, low-density lipoprotein cholesterol lower than 100 mg/dL, and abstinence from tobacco. The primary outcome was analysed in all participants available for follow-up at the relevant timepoint. This trial is registered with Clinicaltrials.gov, NCT02771873. FINDINGS: From Jan 1, 2015, to April 30, 2017, 980 patients with coronary heart disease were assessed for eligibility and 230 were excluded primarily due to lack of evidence of coronary artery disease (n=199), or a diagnosis of coronary heart disease more than 1 year previously (n=29). Of the 750 remaining families, 368 (with 825 participants) were assigned to the intervention group and 382 (with 846 participants) were assigned to the usual care group. At the 2-year follow-up, data from 803 (97%) of 825 participants in the intervention group and 819 (97%) of 846 participants in the usual care group were available. Of the 1671 participants, 1111 (66·5%) were women, and 560 (33·5%) were men. The mean age of the study population was 40·8 years (SD 14·2). At the 2-year follow-up, the primary outcome was achieved by 514 (64%) of 803 participants in the intervention group and 379 (46%) of 819 in the usual care group. After adjustment for clustering and baseline risk factors, the odds of achieving the primary outcome at the 2-year timepoint was two times higher in the intervention group than in the usual care group (odds ratio 2·2, 95% CI 1·7-2·7; p<0·0001). INTERPRETATION: The reduction of total cardiovascular risk observed after the intervention could have a substantial public health impact by preventing future cardiovascular events. FUNDING: The Wellcome Trust and Department of Biotechnology, Government of India, and India Alliance.

Karnataka telemedicine mentoring and monitoring program for complete integration of psychiatry in the general health care.

The National Mental Health Survey of India reported a higher prevalence and treatment gap of psychiatric disorders among the general population. Task shifting is one of the important solutions to meet this requirement. The prevalence of psychiatric disorders among primary care is about 30%-50%. Digitally driven primary care psychiatry program (PCPP) designed to innovate different module to upscale the skills of primary care doctors (PCDs) in live consultation of PCDs in their general patients. To exponential coverage of PCDs, Karnataka Telemedicine Mentoring and Monitoring (KTM) Program is been implemented across all districts of Karnataka. It is the training of trainer version of PCPP where psychiatrists serving in District Mental Health Program of all districts of Karnataka become trainers to implement of two digital modules (Telepsychiatric On-Consultation Training and Collaborative Video Consultations) of PCPP with the target to train all PCDs of Karnataka. This paper aims to provide a glimpse of this innovative KTM program and current progress with a preliminary analysis of translational quotient indicating skill transfer and retention.

Genomic Instability in Exfoliated Buccal Cells among Cement Warehouse Workers.

BACKGROUND: Workers in cement warehouses of Kerala are enduring long-standing exposure to cement dust, which is considered genotoxic. OBJECTIVE: To evaluate the extent of genotoxicity and cytotoxicity caused due to exposure of cement dust among those working in cement warehouses. METHODS: The study included 82 cement warehouse workers and 82 age-matched individuals with no exposure to cement dust. Exfoliated buccal micronucleus cytome assay (BMCyt) was performed to analyze the genotoxic and cytotoxic effects caused by inhalation of cement dust. RESULTS: The frequency of various genotoxic and cytotoxic end markers (micronucleated cells [2-fold increase, p<0.001], nuclear buds [4-fold increase, p<0.001], binucleated cells [4-fold increase, p<0.001], karyorrhectic cells [2-fold increase, p<0.001], pyknotic cells [3-fold increase, p<0.001], and karyolytic cells [2-fold increase, p<0.001]) were higher in the exposed workers compared with unexposed group. Increase of these parameters represented an increased level of chromosomal damage, nuclear disintegration and increased cell death among exposed group compared with unexposed group. CONCLUSION: Continuous exposure to cement dust results in increased frequency of nuclear aberrations and cellular apoptosis. This may lead to defects in genome maintenance, accelerated ageing, increased chance of oral cancer and neurodegenerative disorders in those occupationally exposed to cement dust.

Statistical power estimation in non-invasive brain stimulation studies and its clinical implications: An exploratory study of the meta-analyses.

BACKGROUND: Non-invasive brain stimulation (NIBS) techniques have emerged as a promising tool for understanding and treating psychiatric disorders, necessitating a caution in terms of interpreting research results. OBJECTIVE: This study aimed at systematically evaluating a representative sample of research conducted using NIBS interventions in neuro-psychiatric conditions, and assessing the power these studies achieved, given their sample sizes. METHODS: A database search was conducted with defined keyword combinations. Using reported summary effects of the meta-analyses as estimate of the true effects, we calculated achieved power of each individual study to detect the effect indicated by the corresponding meta-analysis. RESULTS: Findings suggest that mean and median powers in the field of NIBS were 0.50, with a mode at 0.83 (range 0.05-1.00). When analysed separately, the median powers were 0.27 for tDCS, 0.70 for TMS and 0.97 for ECT. These studies had a mean total sample size of 22.2 ±â€¯24.9 subjects and the median reported effect size across all studies was 0.61. CONCLUSION: According to our findings, studies conducted in NIBS miss around 50% of true positive results. Further, it appears that most of the researchers in this field chase statistical significance with small sample sizes, thus compromising the quality of their conclusions.

High burden of prediabetes and diabetes in three large cities in South Asia: The Center for cArdio-metabolic Risk Reduction in South Asia (CARRS) Study.

AIM: To estimate the prevalence of, and assess factors associated with, diabetes and prediabetes in three South Asian cities. METHODS: Using a multi-stage cluster random sample representative of each city, 16,288 subjects aged ≥20 years (Chennai: 6906, Delhi: 5365 and Karachi: 4017) were recruited to the Centre for cArdio-metabolic Risk Reduction in South-Asia (CARRS) Study. Fasting plasma glucose (FPG) and glycosylated hemoglobin (HbA1c) were measured in 13720 subjects. Prediabetes was defined as FPG 100-125 mg/dl (5.6-6.9 mmol/l) and/or HbA1c 5.7-6.4% (39-46 mmol/mol) and diabetes as self-report and/or drug treatment for diabetes and/or FPG≥126 mg/dl (≥7.0 mmol/l) and/or HbA1c≥6.5% (48 mmol/mol). We assessed factors associated with diabetes and prediabetes using polytomous logistic regression models. RESULTS: Overall 47.3-73.1% of the population had either diabetes or prediabetes: Chennai 60.7% [95%CI: 59.0-62.4%] (diabetes - 22.8% [21.5-24.1%], prediabetes - 37.9% [36.1-39.7%]); Delhi 72.7% [70.6-74.9%] (diabetes - 25.2% [23.6-26.8%], prediabetes - 47.6% [45.6-49.5%]); and Karachi 47.4% [45.7-49.1%]; (diabetes - 16.3% [15.2-17.3%], prediabetes - 31.1% [29.5-32.8%], respectively). Proportions of self-reported diabetes were 55.1%, 39.0%, and 48.0% in Chennai, Delhi, and Karachi, respectively. City, age, family history of diabetes, generalized obesity, abdominal obesity, body fat, high cholesterol, high triglyceride, and low HDL cholesterol levels were each independently associated with prediabetes, while the same factors plus waist-to-height ratio and hypertension were associated with diabetes. CONCLUSION: Six in ten adults in large South Asian cities have either diabetes or prediabetes. These data call for urgent action to prevent diabetes in South Asia.

Self-reported tobacco use, knowledge on tobacco legislation and tobacco hazards among adolescents in rural Kerala State.

CONTEXT: Tobacco consumption initiated during the adolescent period is a major contributor to the pathogenesis of fatal diseases in adulthood. Information on tobacco use and awareness regarding tobacco legislation and hazards among adolescents in rural Kerala is limited. AIMS: To assess the prevalence of tobacco use among adolescent students in a rural district in Kerala state and to understand the extent of awareness about the prominent legislative measures against tobacco and tobacco hazards. MATERIALS AND METHODS: Data on awareness regarding health hazards due to tobacco use and legislation against tobacco consumption were collected from students of 15 randomly selected high schools in an educational sub-district in Kerala, using a cross-sectional study design. Chi-square and Fisher's exact test statistics were used for statistical analysis. RESULTS: A total of 1473 students participated in the study, of which 79% were males (mean age 15.4 years, SD 1.5). The overall prevalence of 'current tobacco users' was 8%. A significant association between age and tobacco use was noted among tobacco habitués (P<0.05). Awareness regarding legislation against smoking in public places was more in the higher age-groups (P<0.05). Females were more aware of the 'smoking ban' than males (P<0.05). Our survey of the awareness regarding the hazards associated with tobacco use revealed that 41.5% of the students knew about the link between oral cancer and tobacco, with the awareness being greater among females than among males (64.3% vs 35.4%). CONCLUSION: The finding that tobacco consumption increases with age is a matter of concern. In addition to their clinical work, dental professionals should also educate the public on the hazards of tobacco and conduct tobacco cessation programmes for adolescent groups to control the tobacco epidemic.

Dietary fat and risk of breast cancer.

BACKGROUND: Breast cancer is one of the major public health problems among women worldwide. A number of epidemiological studies have been carried out to find the role of dietary fat and the risk of breast cancer. The main objective of the present communication is to summarize the evidence from various case-control and cohort studies on the consumption of fat and its subtypes and their effect on the development of breast cancer. METHODS: A Pubmed search for literature on the consumption of dietary fat and risk of breast cancer published from January 1990 through December 2003 was carried out. RESULTS: Increased consumption of total fat and saturated fat were found to be positively associated with the development of breast cancer. Even though an equivocal association was observed for the consumption of total monounsaturated fatty acids (MUFA) and the risk of breast cancer, there exists an inverse association in the case of oleic acid, the most abundant MUFA. A moderate inverse association between consumption of n-3 fatty acids and breast cancer risk and a moderate positive association between n-6 fatty acids and breast cancer risk were observed. CONCLUSION: Even though all epidemiological studies do not provide a strong positive association between the consumption of certain types of dietary fat and breast cancer risk, at least a moderate association does seem to exist and this has a number of implications in view of the fact that breast cancer is an increasing public health concern.